A Research Study for Patients With Overactive Bladder - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00168454

Purpose

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Condition	Intervention	Phase
Overactive Bladder Urinary Incontinence	Biological: botulinum toxin Type A Biological: Placebo/botulinum toxin Type A	Phase II

MedlinePlus related topics: Botox Urinary Incontinence

Drug Information available for: Sodium chloride Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Number of incontinence episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of micturitions for 24 hours [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Number of nocturia episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Urodynamic parameters [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Biological: Placebo/botulinum toxin Type A Placebo injection on Day 1 into detrusor
2: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U, 100 U, 150 U, 200 U, 300 U injection on Day 1 into detrusor
3: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U, 100 U, 150 U, 200 U, 300 U injection on Day 1 into detrusor
4: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U, 100 U, 150 U, 200 U, 300 U injection on Day 1 into detrusor
5: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U, 100 U, 150 U, 200 U, 300 U injection on Day 1 into detrusor
6: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 50 U, 100 U, 150 U, 200 U, 300 U injection on Day 1 into detrusor

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be between 18-80 years old
Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
Must weigh at least 50 kg (110 lbs)
Must be willing and able to record information regarding bladder function into a diary (provided)
Must be willing and able to complete the entire course of the study

Exclusion Criteria:

Cannot currently be catheterizing as a way to control incontinence
Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168454

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Irvine, California, United States

Sponsors and Collaborators

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-077
Study First Received:	September 12, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00168454
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Botulinum Toxins
Cystocele
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence
Botulinum Toxin Type A

Additional relevant MeSH terms:

Urological Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009